On September 11, 2026, the Therapeutic Goods Administration (TGA) of Australia published a public notice launching a public consultation on proposed amendments to the Poisons Standard, with feedback due by October 12, 2026.
The proposals were put forward by the TGA's Delegate and cover three substances: Acetophenone (CAS No. 98-86-2), Vitamin A (Retinol, CAS No. 68-26-8), and Methyl ethyl ketone oxime (MEKO)-releasing silanes. Of these, the two directly relevant to cosmetics are Acetophenone and Vitamin A.
Acetophenone: Proposed 0.2% Concentration Threshold for Cosmetic and Household Products
Background
Acetophenone is an aromatic ketone used as a solvent in domestic products, such as paints and paint removers, in combination with other designated solvents. It is also used as a chemical intermediate and fragrance in a range of products including personal care, cleaning and furniture care, laundry and dishwashing, and air care products.
Basis of the proposal
The AICIS evaluation report concluded that, in order to manage potential developmental toxicity and fetotoxicity risks associated with acute and chronic exposure, its concentration and/or functional uses in cosmetics and household products should be restricted.
Current status
Acetophenone is included in the “designated solvents” definition list in Section 6 of Part 1 of the Poisons Standard and, except for preparations containing 25% or less of designated solvents, is classified as a Schedule 5 substance.
Proposed amendment (to the Schedule 5 entry)
Preparations for household and cosmetic use containing 0.2% or less of acetophenone would be exempt. At the same time, Acetophenone would be removed from the “designated solvents” definition list.
International alignment
- The EU Cosmetics Ingredients database (CosIng) lists Acetophenone for fragrance/perfuming purposes;
- The European Chemicals Agency (ECHA) requires acute toxicity (Category 4) and eye irritation (Category 2) hazard classifications;
- The EU Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion in May 2026, concluding that Acetophenone is safe at up to 100ppm (0.01%) when present as a constituent of natural complex substances (NCS);
- The ECHA Committee for Risk Assessment (RAC) recommended in March 2025 that Acetophenone be classified as a reproductive toxicant Category 1B (H360FD), on which basis the European Commission may propose a ban on its use in cosmetics.
Vitamin A: Proposed Switch to Retinol Equivalents with Tightened Topical Limits
Background
Vitamin A is a fat-soluble vitamin that is present in food, dietary supplements and therapeutic goods. It is also used in a range of cosmetic products available in Australia, including face creams, body lotions, hand creams, nail products and lip products.
Basis of the proposal
Retinol and Retinyl esters are known human developmental toxicants, with effects primarily associated with their conversion to retinoic acid. The AICIS evaluation concluded that systemic exposure from cosmetics (particularly where multiple products are used simultaneously) may exceed the tolerable upper intake level (UL, 3,000 micrograms RE/day) for teratogenicity and the guidance level (GL, 1,500 micrograms RE/day) relevant to bone health.
Current status
Vitamin A for human therapeutic or cosmetic use is listed in Schedule 4 (prescription-only medicine), with exceptions including topical preparations containing 1% or less of vitamin A. The entry covers retinol and its esters.
Proposed amendment (to the Schedule 4 entry)
Vitamin A for human therapeutic or cosmetic use would be exempt in the following cases:
- topical preparations in the form of body lotions containing 0.05% retinol equivalents (RE) or less;
- other topical preparations containing 0.3% RE or less;
- preparations for internal use with a daily dose of 3,000 micrograms RE or less;
- preparations for parenteral nutrition replacement.
It is also proposed to add cross-references in the Poisons Standard Index, clarifying that the entry covers Retinol (CAS 68-26-8), Retinyl palmitate (CAS 79-81-2), Retinyl acetate (CAS 127-47-9), Retinyl linoleate (CAS 631-89-0), and Retinyl propionate (CAS 7069-42-3).
International alignment
- The EU has set the maximum concentrations of Vitamin A and its derivatives in cosmetics at 0.05% RE for body lotions and 0.3% RE for leave-on and rinse-off products other than body lotions;
- Canada has set a limit of 0.2% total RE for leave-on products for application to the whole body and 1.0% for other cosmetics. This proposal aims to align with the EU limits.
Next steps
The proposals will be considered at the 43rd meeting of the Advisory Committee on Chemicals Scheduling (ACCS), to be held in November 2026. Following the ACCS meeting, the Delegate will make an interim decision taking into account the committee's advice and public submissions. Under the TGA scheduling procedure, interim decisions are generally published for further submissions before the final decision is made.
Implications and Recommendations for Cosmetic Enterprises
1. Conduct formulation screening: review the formulas of products sold in, or intended for export to, Australia, focusing on the actual concentrations of Acetophenone and Vitamin A, and assess compliance gaps against the proposed limits;
2. Recalculate retinol equivalents: given that different retinyl esters have different RE conversion factors, the calculation of formulation concentrations shall be redone according to the specific ester used, and the former 1% basis should no longer be relied upon;
3. Watch for knock-on effects in the EU: the SCCS has set 0.01% as the safe threshold for Acetophenone in cosmetics, and the ECHA RAC has recommended classifying it as a reproductive toxicant Category 1B; should the EU implement a ban, raw material availability and formulation choices would be affected at the same time, and it is advisable to prepare alternative options in advance;
4. Plan for transitional arrangements: once the proposal progresses, an interim decision will first be published, to be followed by a second round of consultation and transitional arrangements; enterprises are advised to continue tracking the outcome of the ACCS meeting and subsequent updates to the Poisons Standard, and to check product labels and compliance documents accordingly.
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